Using Community Health Workers to Support Rural Care Partners of Seriously Ill Older Veterans

NCT ID: NCT06963970

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-16

Study Completion Date

2028-09-30

Brief Summary

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The investigators aim to support care partner's well-being and satisfaction with VA care and decrease their work burden by offering extra support from a trained Community Health Worker who will help connect the care partner to helpful resources in their communities and in the VA. The investigators also hope to help Veterans well-being and satisfaction with VA care by supporting their care partner more sufficiently allowing the care partner to focus on caregiving tasks.

Detailed Description

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Aim 1: Determine CSNAV effectiveness in increasing rural Veterans' well-being, reducing rural care partner burden, and increasing rural care partner/Veteran satisfaction with VA care in the intervention group compared with the usual care (CSP) group. The investigators will apply a 6-month intervention in a randomized control trial over 27 months. Primary Outcome: (H1) Care partners randomized to intervention group will have lower mean Zarit-1216 burden scores at 6 months compared to the control group. Secondary Outcomes: (H2) Care partners and Veterans randomized to the intervention group will have higher mean CAHPS Global Satisfaction17 scores at 6 months compared to the control group. (H3) Veterans randomized to the intervention group will have higher mean Warwick Edinburgh Mental Well-Being Scale18 scores at 6 months compared to the control group.

Aim 2: Following intervention, the investigators explore Veterans' and care partners' experience of CHWs as a mode of VA support using semi-structured interviews. The investigators then facilitate Delphi Method sessions with the Community Advisory Board plus study Veterans/care partners, CHWs, and key operational partners to examine Aims 1 \& 2 data for intervention improvements and implementation planning using updated CFIR.19

Aim 3: Conduct budget impact analysis from the VA perspective to evaluate cost-drivers and assess feasibility to inform adaptation and implementation of the intervention within a VA regional network.

Conditions

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Dementia Cancer Renal Disease Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Enrolled Care Partners are randomized to the study. The control arm is care partners of seriously ill veterans who are enrolled in the Caregiver Support Program and the intervention arm is care partners of seriously ill veterans who are enrolled in the Caregiver Support Program PLUS receiving a study-provided community health worker for additional support.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Study staff collecting baseline and 6 month measures will be masked to the arm enrollment of participants.

Study Groups

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Community Health Worker support

Additional weekly remote support of care partner using a trained/certified community health worker

Group Type EXPERIMENTAL

Remote Community Health Worker support

Intervention Type OTHER

trained/certified community health worker supporting care partner remotely

Regular support

Regular care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Remote Community Health Worker support

trained/certified community health worker supporting care partner remotely

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* A relative, friend, or partner (18 years of age) with whom Veteran patient has a personal relationship who assists Veteran regularly with care and/or care coordination as defined under "Veterans" below
* Residing in a rural area based on RUCC or Rural-Urban Continuum Codes83
* Must be enrolled in CSP Program of General Caregiver Support Services
* Can live with or separately from the Veteran; able to communicate in English by phone


* Receiving care at Durham, Asheville, and Richmond VA Health Systems (e.g., at least 2 outpatient visits in past year; has a primary provider) and residing in a rural area.
* Diagnosed with congestive heart failure, chronic obstructive pulmonary disease, cancer, dementia, or end-stage renal disease.
* Requires assistance with at least one ADL (i.e., walking, feeding, toileting, transferring, bathing, or dressing) or IADL (i.e., transport, medication, financial management, shopping, or meal preparation)
* 50 years old or older and able to communicate in English by phone (for assessments)

Exclusion Criteria

* Flag or social work note indicating suspected Caregiver abuse.
* Unable to communicate in English by phone for assessments.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Durham VA Medical Center

FED

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathan A Boucher, DrPH

Role: PRINCIPAL_INVESTIGATOR

Durham VA Medical Center, Durham, NC

Locations

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Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Site Status

Countries

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United States

Central Contacts

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David Edelman, MD MHS

Role: CONTACT

(919) 286-6926

Jennifer B Zervakis, PhD

Role: CONTACT

(919) 286-0411 ext. 176174

Facility Contacts

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Jennifer B Zervakis, PhD

Role: primary

(919) 286-0411 ext. 176174

Other Identifiers

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1l01HX003922-01A1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SDR 24-078

Identifier Type: -

Identifier Source: org_study_id

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